Quality Engineer

Role Purpose

Reporting directly to the Quality Manager, this position involves product team support for the manufacturing operations, provides quality guidance, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and projects teams for new product introduction, process improvements, continuous improvements, and validation activities. This position works closely with other functions within the organization (Manufacturing, R&D, Continuous Improvement, Engineering, Procurement and Marketing) and is responsible for the quality of the product and process.

Key Responsibilities

• Provide product team support including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions.
• Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc.
• Facilitates investigation of Nonconforming Process Report (NCPR), Situation Analysis (SA), and Health Hazar Evaluation (HHE) with clear documentation of corrective actions.
• Lead discussion on blocked stock and open notifications in Material Review Board (MRB)
• Assist with the investigation of Corrective & Preventive Actions (CAPA), non-conforming product, and customer complaints, providing solutions where possible. Communicate customer feedback to Quality Systems group.
• Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, DOE, MSA, Validation Protocol development, review and approval and Control Plans.
• Support Continuous Improvement activities and key plant projects.
• Develop/Revise Quality Plans including: incoming, in-process and final inspection, and provide training to those affected by the plans.
• Implement proven inspection and metrology improvements and associated training.
• Review and approve Project Design History Files.
• Create technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO Standards.
• Serve as a resource for performing internal audits to ensure quality system compliance.
• Able to react to change and perform other duties as assigned.

Experiences/Education - Required

• Bachelor’s Degree in a technical discipline. (Process or Plastics Engineering preferred)
• Manufacturing quality engineering experience
• Regulated industry experience such as health care, medical device, pharmaceutical, etc).
• Green or Black belt
• Proficiency and/or working knowledge of databases and programs (i.e. SAP, EtQ, Access, Excel, Microsoft project, Minitab)

Hours of work:

• Standard business hours; Monday – Friday.  Flexibility required to accommodate interactions with all shifts within a 24/7 manufacturing operation.

Travel Requirements:

• Up to 5% domestic and international

Experiences/Education - Desired

• Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.
• Ability to make decision regarding product disposition and corrective and preventive action effectiveness. Comfortable in giving direction to accomplished assigned tasks.
• Knowledge of manufacturing processes and relevant statistical method for quality assurance, i.e., capable of Six-Sigma skills, certification preferred.
• Good understanding of Continuous Improvement Methodologies, including lean, six sigma, statistical applications and validation.
• Proficiency in Minitab, Microsoft Project, word processing, database, and spreadsheet applications.
• Demonstrated technical writing skills.
• Thorough knowledge of the regulatory industry requirements ISO13485, ISO15378, Quality Management Systems, Regulation CFR 21 part 820, GDP / cGMP